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Monika Nayaka

@monikanayaka

Clinical Research Coordinator at Apollo Research and Innovations, supporting Phase II–IV trials and inspection readiness.

India

Message

At Apollo Research and Innovations, Apollo Hospitals, I supported Phase II–IV clinical trials from start-up through close-out. I coordinated trial activities, maintained regulatory binders and essential documents, and supported inspection readiness.

I also handled EDC/eCRF data entry and query resolution, while coordinating informed consent documentation, IP accountability, and biological sample shipments. At Orca1.ai, I supported FDA 510(k) predicate validation and Form 483 review, contributing to regulatory documentation and inspection readiness.

Experience

Work history, roles, and key accomplishments

Regulatory Data Validation Intern

Orca1.ai

Jan 2025 - May 2025 (4 months)

Supported FDA 510(k) predicate validation and Form 483 review to strengthen regulatory compliance tracking, data integrity, and inspection readiness. Assisted with regulatory document classification, data review, and compliance documentation.

510(K)Form 483 Regulatory Compliance Data Validation Document Classification data review Compliance Documentation Quality Control Document Management

Clinical Research Coordinator

Apollo Research and Innovations

Jul 2021 - Jul 2022 (1 year)

Supported Phase II–IV clinical trials across study start-up, conduct, and close-out in compliance with ICH-GCP, FDA, IRB/EC, HIPAA, sponsor protocols, and site SOPs. Coordinated daily trial activities including subject visit planning, study trackers, and source documentation.

Clinical Trial Coordination Study Start Up Study Execution Study Closeout ICH GCP FDA IRB EC Responsibilities HIPAA Research participant recruitment Informed Consent Forms EDC ECRF Query Resolution Data Reconciliation IP Accountability Sample Shipment Management Regulatory Binder Monitoring Visits Sponsor Communication

Clinical Research Coordinator Intern

Apollo Research and Innovations

Jan 2020 - Oct 2020 (9 months)

Assisted with EC/IRB submissions, study amendments, document collection, and regulatory binder setup to support timely study approvals and start-up readiness. Supported subject-level activities including informed consent documentation and GCP-compliant study documentation.